DHA For The Treatment of Pediatric Concussion Related to Sports Injury

Completed · Phase 1 · Has a placebo group

Conditions studied: Concussion, Mild Traumatic Brain Injury

In brief

In recent years, media attention has focused on the long-term sequelae of repeated concussive episodes in professional athletes. The growing understanding of the damage done by what was once considered a "ding" during a game or match, and the neurologic consequences of "playing through" or returning to play too soon has led to additional interest in and concern for pediatric athletes (18 or under) who experience sports-related concussions during game or practice play. Because it has only been in recent years that the full scope of damage done by repeated concussive episodes has come to light, very little research has been done on treatment of concussion in either adults or children. Brain injuries in children can be especially problematic, as the brain may continue to develop until the child reaches the age of 24 or older, so concussion during this time of development may be particularly damaging. Docosahexaenoic acid (DHA) is an omega-3 fatty acid commonly found in both fish oils and algae. DHA is known to improve development of the eyes and brain in young children. It is thought to be an effective anti-inflammatory and anti-oxidant, and since it occurs naturally and causes very few harmful side effects, it may be a useful compound in the treatment of pediatric concussion. This is a feasibility trial of DHA for the treatment of sports concussion in a pediatric population. The investigators' primary aim is to determine acceptability of randomization for this compound as well as rate of enrollment given our clinical population. The investigators' secondary aim is to examine preliminary outcomes. The investigators hypothesize that subjects who take 2 g of DHA daily for 3 months will see a shorter time to full recovery and return to play and a shorter time to resolve balance disturbance. These are good, albeit unvalidated, clinical indicators of concussive recovery.

Key facts

Study ID

NCT01903525

Run by

University of Texas Southwestern Medical Center

People needed

40

Starts

2013-09-01

Expected to finish

2017-08-01

Last updated by the study team

2021-01-11

Who can join

Age: 14 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or females age 14-18 inclusive
• Diagnosed with concussion due to sports-related injury. Concussion is defined as:
• Direct blow to the head, face, neck or a blow elsewhere on the body with an "impulsive" force transmitted to the head.
• Rapid onset of short-lived impairment of neurologic function in one or more of the following clinical domains that resolves spontaneously:
• i. Symptoms: somatic (eg, headache), cognitive (eg, feeling like in a fog and/or emotional symptoms (eg, lability).
• ii. Physical signs (eg, loss of consciousness, amnesia).
• iii. Behavioral changes (eg, irritability).
• iv. Cognitive impairment (eg, slowed reaction times).
• v. Sleep disturbance (eg, drowsiness). c) No abnormality on standard structural neuroimaging studies, if such neuroimaging studies are completed for a clinically-indicated reason. Note: neuroimaging is not a part of this study protocol. Study participants will not undergo neuroimaging as part of this study.
• Concussion within 4 days of enrollment
• Presenting for treatment to the Sports Medicine Center at Children's Medical Center

You may not qualify if…

• Subjects not actively participating in an organized sport at time of enrollment
• Subjects who received a concussion from an event other than playing a sport (motor vehicle accident, fall, etc.)
• Subjects who participate in or received a concussion during participation in motorized sports (i.e., motorcross, dirt biking, jet skiing, etc.)
• Subjects with radiographic evidence of traumatic brain injury (i.e., skull fracture, intracranial hemorrhage, cerebral contusion, etc).
• Subjects with a prior diagnosed concussion in the previous 6 months.
• Pregnant women.
• Subjects sensitive to aspirin
• Subjects diagnosed with high blood pressure and currently being treated with blood pressure medications
• Subjects allergic to soy bean oil or corn oil.
• Subjects currently taking fish oil or DHA supplements.

Where it is running

• Sports Medicine at Texas Scottish Rite Hospital for Children — Plano, Texas, United States

Full record on ClinicalTrials.gov

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